US FDA approves GSK's Incruse Ellipta for COPD

The US Food and Drug Administration has approved UK pharma major GlaxoSmithKline’s (LSE: GSK) Incruse (umeclidinium) for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Umeclidinium is GSK’s first once-daily anticholinergic, a type of bronchodilator also known as a long-acting muscarinic antagonist (LAMA), and is contained in the Ellipta inhaler. The FDA-approved strength is 62.5mcg. The Phase III pivotal programme for umeclidinium included seven clinical studies which involved over 2,500 COPD patients treated with umeclidinium or placebo.

Darrell Baker, senior vice president and head, GSK Global Respiratory Franchise, said: “We believe Incruse Ellipta, our first monotherapy in the anticholinergic class, will be an important once-daily treatment option for appropriate patients with COPD. GSK has a long-standing commitment to the development of respiratory medicines in order to offer physicians a choice of treatment options for their patients. We are delighted by this approval, and are looking forward to making Incruse Ellipta available for appropriate patients with COPD in the US.”